QA Engineer R&D
QA Engineer R&D
Generaal de Wittelaan 11B Mechelen Belgium
Biocartis is an innovative molecular diagnostics company committed to revolutionize molecular testing with its unique proprietary IdyllaTM platform. We provide next generation diagnostic solutions aimed at improving clinical practice for the benefit of patients, clinicians, payers and the healthcare industry, with a focus on oncology. Biocartis’ proprietary molecular diagnostics (MDx) IdyllaTM platform is a fully automated sample-to-result, real-time PCR system that offers accurate, highly reliable molecular information from virtually any biological sample, in virtually any setting, allowing fast and effective treatment selection and treatment progress monitoring. Biocartis employs over 450 people and is headquartered in Mechelen, Belgium.
QA Engineer R&D
The Quality engineer R&D is responsible to support assay development projects from the quality perspective.
To support assay development project teams, both internally and external development partners
To provide input from a quality and compliance perspective;
To support the creation of qualification and validation documents in relation with assay projects;
To review project documentation, mainly DHF;
To own the risk management process within the assay project;
To ensure assay-dependent issues, deviations and design changes are adequately investigated and documented;
To establish and maintain an adequate quality mindset in the assay projects;
To provide generic QA support to Menu Development
Contribute to equipment, method and supplier qualifications;
Contribute to continuous process improvements and to support the SOP creation or updates;
Contribute to event and change management related to Menu Development: ensuring that assay-independent issues, deviations and changes are adequately assessed, investigated and documented;
To participate in company-wide QA support such as performing internal audits
Academic level in Molecular Biology, engineering, chemistry, pharmacy or equivalent;
Preferably > 2 years of experience in healthcare industry, preferably in QA;
Preferably experience in the medical devices and/or in the IVD industry;
Knowledge on ISO 13485, 21 CFR part 820 and ISO14971, ISO62366 as well as knowledge on technical standards, e.g. ISO62304 and GAMP;
Ability to effectively interact with the project leader and the technical assay development lead when representing the Quality domain
Skills: Highly accurate, Achievement Orientation, Customer Service orientation, Conceptual thinking, Decision-making, Hands on, Developing others, Team Player;
Languages: advanced knowledge, orally and in writing of Dutch and English;
Electronic Document Management System (MasterControl);
Quality Event Monitoring System (MasterControl).
We offer you a challenging job in an exciting environment, working for top entrepreneurs in the biotech industry. You can be part of a very dynamic, young and growing team in a highly innovative environment. You will have freedom to shape your work and shape your job. Your input is highly appreciated. Of course we offer you a fitting compensation package.
Interested? Please apply via HR@biocartis.com